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Collaborators:

National Heart, Lung, and Blood Institute (NHLBI)

Massachusetts General Hospital

Stanford University

University of Pittsburgh

University of Minnesota - Clinical and Translational Science Institute

This is a Phase 1, open label, dose escalation, multi-center clinical trial of Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells (hMSCs) for the treatment of Acute Respiratory Distress Syndrome (ARDS). The purpose of this study is to assess the safety of hMSCs in patients with ARDS.

Any of the following occurring within 6 h of mesenchymal stem-cell infusion:

Addition of a third vasopressor or an increase in vasopressor dose greater than or equal to the following:

Norepinephrine: 10 μg per min

Phenylephrine: 100 μg per min

Dopamine: 10 μg/kg per min

Epinephrine: 0·1 μg/kg per min

Hypoxaemia requiring an increase in the fraction of inspired oxygen of ≥0·2 and increase in positive end-expiratory airway pressure level of 5 cm H2O or more to maintain transcutaneous oxygen saturations in the target range of 88-95%

New cardiac arrhythmia requiring cardioversion

New ventricular tachycardia, ventricular fi brillation, or asystole

A clinical scenario consistent with transfusion incompatibility or transfusion-related infection

The number of participants with a severe adverse event during the study was assessed.

Ventilator Free Days at Study Day 28 [ Time Frame: time of initiating unassisted breathing to day 28 ]

Ventilator Free Days (VFDs) to day 28 were defined as the number of days from the time of initiating unassisted breathing to day 28 after randomization, assuming survival for at least two consecutive calendar days after initiating unassisted breathing and continued unassisted breathing to day 28. If a subject received assisted breathing at day 27 or died prior to day 28, a value of zero VFDs was given.

Duration of Vasopressor Use (Days) [ Time Frame: 28 days ]

Days on vasopressor to day 28 after study enrollment

ICU Free Days to Day 28 [ Time Frame: 28 days after study enrollment ]

Hospital Survival to Day 60 [ Time Frame: 60 days after randomization ]

The number of subjects alive at study day 60. Those subjects discharged home prior to day 60 were counted as alive at day 60.

A dose-escalation with 3 cohorts with 3 subjects/cohort who receive doses of 1, 5 and 10 million cells/kg predicted body weight (PBW). Proceed from lower dose to next higher dose if no safety concerns for each cohort.

The primary objective of this study is to assess the safety of intravenous infusion of Allogeneic Bone Marrow-Derived Human Mesenchymal Stem Cells (hMSCs) in patients with ARDS.

Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:

18 Years and older (Adult, Senior)

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

No

Criteria

Inclusion Criteria:

Patients will be eligible for inclusion if they meet all of the below criteria. Criteria 1-3 must all be present within a 24-hour time period and at the time of enrollment:

Acute onset (defined below) of:

A need for positive pressure ventilation by an endotracheal or tracheal tube with a PaO2/FiO2 ratio < 200 with at least 8 cm H2O positive end-expiratory airway pressure (PEEP)

No clinical evidence of left atrial hypertension for bilateral pulmonary infiltrates.

In addition to meeting inclusion criteria, enrollment must occur within 96-hours of first meeting ARDS criteria per the Berlin definition of ARDS.

Exclusion Criteria:

Age less than 18 years

Greater than 96 hours since first meeting ARDS criteria per the Berlin definition of ARDS

Pregnant or breast-feeding

Prisoner

Presence of any active malignancy (other than non-melanoma skin cancer) that required treatment within the last 2 years

Any other irreversible disease or condition for which 6-month mortality is estimated to be greater than 50%

Moderate to severe liver failure (Childs-Pugh Score > 12)

Severe chronic respiratory disease with a PaCO2 > 50 mm Hg or the use of home oxygen

Patient, surrogate, or physician not committed to full support (exception: a patient will not be excluded if he/she would receive all supportive care except for attempts at resuscitation from cardiac arrest).